Chronic myelogeneous leukemia CML
Conditions
Interventions
The patient is intradermally injected with 1 mg of the HLA-A*2402-restricted, modified 9-mer WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was schedule
Sponsors
Department of Cancer immunotherapy, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Diagnosed as CML 2. Informed about his diagnosis 3. HLA-A*2402 positive 4. No chemotherapy/radiation except Imatinib has been performed within 4 weeks before the start of vaccination. 5. Dose of Imatinib has not been changed within 4 weeks 6. Require a minimum of 18 months elapse 7. Status of diasese is chronic phase. 8. His diasese is not changed within 3 months . 9. Meet the following criteria Neutrophil more than 1,500/microliter, Platelet more than 100,000/microliter, Hemoglobin more than 8g/dl 10. Aged 16 and over, and 79 and under 11. Performance Status (ECOG) 0-1 12. Adverse effect by Imatinib is tolatated. 13. Meet the following criteria for organ functions Serum creatinine less than 1.5 folds of the upper normal limit. Serum bilirubin less than 1.5 folds of the upper normal limit Serum AST/GOT less than 3 folds of the upper normal limit Arterial oxygen saturation more than 94% in room air 14. ECG: no severe abnormality 15. Informed consent has been obtained 16. Survival period is expected more than 3 months.
Exclusion criteria
Exclusion criteria: 1. Post allogeneic hematopoietic stem cell transplantation 2. There is deep-seated active infection. 3. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis. 4. Patients who have complications that are considered inappropriate for the trial. 5. Pregnant or lactating woman 6. There is severe psychiatric disorder. 7. There are other active malignancies. 8. Responsible doctors judged the patient inappropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Phase I) Safety is evaluated by NCI-CTCAE v3.0. (Phase II) Hematological Response Cytogenetic Response Molecular Response | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune response to WT1 | — |
Countries
Japan
Contacts
Public ContactYoshihiro Oka
Osaka University Graduate School of Medicine Department of Cancer Immunotherapy
Outcome results
None listed